Impact of Non-intentional Leaks on Noninvasive Ventilation

AGIR à Dom20 enrolled

Overview

The investigators hypothesized that increasing non intentional leaks could increase work of breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony. The main objective is to compare ventilatory pattern (work of breathing, flow, pressure) under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10 awakened and asleep obese hypoventilation syndrome (OHS) patients. Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a random order with an automatically opening valve. Breathing pattern (work of breathing,flow, pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects will be recorded only during awakened state. OHS patients will be recorded both during awake and sleep sates. Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing according to the different levels of leaks.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intermittent Positive-pressure Ventilation Respiratory Physiological Phenomena

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * OHS patients, in stable stade, teated with nocturnal non invasive ventilation for at least three months. * Healthy subjects without known pathology Exclusion Criteria: * OHS patients: instable cardio-respiratory status and/or acute cardio-respiratory failure three month before the inclusion. Latex allergy, oesophageal varices.

Outcomes

Primary Outcomes

Main outcome measure:Work of breathing assessed by measurement of oesophageal pressure according to the levels of non intentional leaks during non invasive ventilation

Time frame: Oesophageal pressure will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients)

Secondary Outcomes

Secondary outcome measure: Assessments of the pulse transit time (PTT) and measurement of the oral opening (JAWSENS-NOMICS)according to the levels of non intentional leaks during non invasive ventilation

Time frame: PTT and oral opening will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients)